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Johnson & Johnson Provides Update on McNeil Consumer Healthcare Remediation; Announces Completion of Internal Assessment Phase of Comprehensive Action Plan
Date:1/14/2011

NEW BRUNSWICK, N.J., Jan. 14, 2011 /PRNewswire/ -- McNeil Consumer Healthcare Division of McNeil-PPC, Inc., a Johnson & Johnson (NYSE: JNJ) company, in July 2010 submitted to the FDA a Comprehensive Action Plan on quality improvement, and made a commitment to restore its operations to the level of quality and compliance that people expect of all Johnson & Johnson companies. As part of this commitment, McNeil undertook a thorough investigation of historical records, as far back as 2007, for products sold in the U.S. and produced in McNeil's internal manufacturing network.  For each product, McNeil looked at whether the right processes had been identified and followed, and evaluated whether quality standards had been met. This assessment has now been completed, representing a significant milestone in the Comprehensive Action Plan.  

The assessment identified a number of areas for improvement, which are being addressed. For example, McNeil identified instances where equipment cleaning procedures were insufficient or cleaning was not adequately documented. These issues occurred at McNeil's Fort Washington, PA manufacturing plant, prior to April 2010, when production at the facility was suspended. McNeil also discovered one product for which the labeling did not include all information required by regulations.  In line with the company's unqualified commitment to quality and compliance, McNeil today announced a wholesale-level recall of products affected by these issues. (Click HERE to access recall information.) This recall does not come as a result of adverse events.

Johnson & Johnson Chairman and CEO Bill Weldon said, "Steps we have taken under the Comprehensive Action Plan constitute an uncompromising and systematic effort to review quality and manufacturing practices at McNeil. They help us ass
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SOURCE Johnson & Johnson
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